Contractor Genentech, Inc South San Francisco, California, United States
Background: Characterization of QTc prolongation risk, or drug-induced prolongation of cardiac electrical conduction, is essential for determining the safety profile of new drug candidates. Concomitant medication use may exacerbate the risk of adverse cardiac events from QTc prolongation; understanding this risk in a real world patient population can help inform clinical practice, inspire trial design, and ensure patient safety during drug development. Methods: IQVIA PharMetrics® Plus, a US health plan claims database (01/2010 to 03/2020), was utilized to characterize concomitant medication use and existing QTc prolongation risk via retrospective cohort analysis in breast cancer patients. The cohort includes female patients with at least two breast cancer diagnoses coded within one month to one year through 2020 in addition to exposure to systemic cancer treatments. Comorbidities and use of concomitant medications (30 days post-diagnosis) were characterized and compared. QTc drugs were denoted using the Credible Meds database. Results: 253,046 (median age: 57) patients were selected from PharMetrics Plus, with most prevalent comorbid conditions of diabetes without chronic complications (9.1%) and chronic pulmonary disease (6.9%) (Figure 1A). Top systemic cancer treatments (with possible QTc risk) including tamoxifen and capecitabine. Prevalent concomitant non-cancer medications (with known or possible QTc risk) include azithromycin, fluconazole, omeprazole, levofloxacin, hydrochlorothiazide, ondansetron, and lapatinib (Figure 1B). Conclusion: Use of concomitant drugs (with QTc prolongation risk) includes systemic treatments and antibacterials/antifungal agents, acid reduction agents, and antiemetics. Real world claims data therefore provides a means to inform adverse event risk and influence future drug development or practice patterns.
